Airborne Particle Counters

Contamination Control Strategy (CCS)

The recommended approach to the CCS follows basic HACCP principles where the product and the process are reviewed in its entirety to fully understand each unit operation and to determine the potential contamination hazards and the measures in place at each step to prevent the hazard from occurring.  The CCS should be documented and needs continuous improvement if new hazards are detected. Following elements are veru important in the Contamination Control Strategy: Raw materials controls like WFI, Cleanring & Disinfection, Facility Monitoring Systems, process design, outsourced services, Pharmaceutical Quality Systems (PQS) and Risk Assessments.

MET ONE range of particle counters

The MET ONE particle counters are available as portable-, remote- or handheld particle counters. In general the portable particle counters and handheld particle counters are most often used for cleanroom qualification purposes. For monitoring applications remote particle counters are more often used combined with a central vacuum system or a particle counter with an internal vacuum pump.

Cleanroom qualifications (or classifications) are usually carried out every 6 months to demonstrate that the cleanroom is fit for use by measuring particle counts, removal efficiencies, microbial activity levels, air change rates and many other parameters. In general these studies are carried out at-rest and not in the operational state.

The air cleanliness is measured against a particle limit in a specified volume of air depending on the cleanroom class according to ISO14644-1 or GMP Annex 1, which give clear pass/fail criteria.